Panels › Cardiovascular › Product code NAJ · Class 2
Agents, Embolic, For Treatment Of Uterine Fibroids
Regulation 870.3300
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NAJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 2 | 1 |
| Merit Medical Systems, Inc. | 2 | 0 |
| Biosphere Medical, Inc. | 1 | 0 |
| Celonova Biosciences, Inc. | 1 | 0 |
| Cook Incorporated | 1 | 0 |
| Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2023 | K233813 | Bearing nsPVA Express Merit Medical Systems, Inc. | NAJ |
| Sep 17, 2018 | K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres Suzhou Hengrui Callisyn Biomedical Co., Ltd., CN | NAJ |
| Feb 24, 2014 | K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES Celonova Biosciences, Inc. | NAJ |
| Jun 7, 2013 | K130259 | BEARING NSPVA EMBOLIZATION PARTICLES Merit Medical Systems, Inc. | NAJ |
| Apr 16, 2010 | K100663 | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 Boston Scientific Corporation | NAJ |
| Dec 23, 2008 | K081768 | COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES Cook Incorporated | NAJ |
| Sep 23, 2003 | K030966 | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER Boston Scientific Corp | NAJ |
| Nov 22, 2002 | K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION Biosphere Medical, Inc. | NAJ |
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